This Little Red Pill is One to Watch

It’s called Nuedexta—and it is intended to treat a rare condition called pseudobulbar affect, or PBA—a disorder marked by sudden and uncontrollable laughing or crying. Even though this condition affects less than one percent of all Americans, the use of the drug in long-term care facilities has skyrocketed in the past six years. Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities.

Drug maker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients but says that PBA can occur in patients with dementia. In a recent CNN article, dementia researchers and other medical experts said that PBA is extremely rare in dementia patients, affecting five percent or less. And state regulators have found doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior makes them difficult to manage.

And who foots the bill for all of that? The federal government pays for a large portion of the money being spend on Nuedexta in the form of Medicare Part D prescription drug funding for people 65 and older and the disabled. In 2015, that number jumped 400% from 2012 to the tune of $138 million.

Soon after Nuedexta hit the market in 2011, doctors, nurses and family members began filing reports of potential harm, ranging from rashes, dizziness and falls to comas and death. Nuedexta was listed as a suspect medication in nearly 1,000 so-called adverse event reports received by the FDA detailing side effects, drug interactions and other issues. Across the country, the use of Nuedexta in nursing homes has prompted concerns among state regulators whose job is to ensure adherence to federal guidelines and protect residents from being given unnecessary drugs—especially those used as chemical restraints.

If your loved one is in a nursing home, it is important to be aware of all medications that have been prescribed for them, especially if one has been prescribed for a condition you are not aware of. If your loved one has experienced harm due to Nuedexta or any other prescription drug, Burke Harvey is here to help. Contact our attorneys today.